NIFEDIPINE - Generic Drug Details
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What are the generic sources for nifedipine and what is the scope of freedom to operate?
Nifedipine
is the generic ingredient in six branded drugs marketed by Bayer Pharms, Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Teva, Velzen Pharma Pvt, Pfizer, Norwich, Watson Labs, Watson Labs Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Endo Operations, Martec Usa Llc, Norvium Bioscience, Novast Labs, Osmotica Pharm Us, Rising, Spil, Swiss Pharm, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-nine drug master file entries for nifedipine. Thirty-eight suppliers are listed for this compound.
Summary for NIFEDIPINE
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 27 |
| NDAs: | 36 |
| Drug Master File Entries: | 39 |
| Finished Product Suppliers / Packagers: | 38 |
| Raw Ingredient (Bulk) Api Vendors: | 165 |
| Clinical Trials: | 165 |
| Patent Applications: | 7,023 |
| Drug Prices: | Drug price trends for NIFEDIPINE |
| Drug Sales Revenues: | Drug sales revenues for NIFEDIPINE |
| What excipients (inactive ingredients) are in NIFEDIPINE? | NIFEDIPINE excipients list |
| DailyMed Link: | NIFEDIPINE at DailyMed |
Recent Clinical Trials for NIFEDIPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Marshall University | Phase 2 |
| Queen Mary University of London | N/A |
| Medical College of Wisconsin | Phase 3 |
Pharmacology for NIFEDIPINE
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for NIFEDIPINE
Anatomical Therapeutic Chemical (ATC) Classes for NIFEDIPINE
US Patents and Regulatory Information for NIFEDIPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | NIFEDIPINE | nifedipine | CAPSULE;ORAL | 072651-001 | Feb 19, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novast Labs | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 210614-003 | Mar 12, 2019 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novast Labs | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 202987-003 | Aug 25, 2016 | AB1 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Spil | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 210838-002 | Apr 16, 2019 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Heritage Pharma | NIFEDIPINE | nifedipine | CAPSULE;ORAL | 202644-002 | Apr 25, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 201071-001 | Dec 3, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 210012-001 | Dec 19, 2017 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NIFEDIPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-001 | Sep 6, 1989 | ⤷ Sign Up | ⤷ Sign Up |
| Norwich | ADALAT CC | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 020198-003 | Apr 21, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Norwich | ADALAT CC | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 020198-002 | Apr 21, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Pharms | ADALAT | nifedipine | CAPSULE;ORAL | 019478-001 | Nov 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-003 | Sep 6, 1989 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-002 | Sep 6, 1989 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Pharms | ADALAT | nifedipine | CAPSULE;ORAL | 019478-002 | Sep 17, 1986 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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